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Summary of Field Safety Notices - October 2017
Notice type:
3rd Party Publications
Date:
02/11/2017
Further Information:
Abbott
Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™, and Unify Quadra
Advice regarding the use of the device. HPRA Ref: V33046
Alba Bioscience Limited
ALBAcyte Reagent Red Cells for Antibody Identification (Papainised)
Advice regarding a device removal. HPRA Ref: V33513
Biomerieux
VITEK 2 GP ID
Advice regarding the use of the device. HPRA Ref: V33570
Carefusion/ BD
Alaris™ / Asena ™ GS, GH, CC, TIVA, PK, Syringe Pump- Pre 2008
Advice regarding the use of the device. HPRA Ref: V33494
Cepheid
Xpert EV® assay
Advice regarding a device removal. HPRA Ref: V33503
Cook Medical Europe
Wills-Oglesby Percutaneous Gastrostomy Set
Advice regarding a device removal. HPRA Ref: V33658
CR Bard
BARD MAX-CORE Disposable Core Biopsy Instrument
Advice regarding a device removal. HPRA Ref: V33583
Datex-Ohmeda, Inc.
Carestation 620, Carestation 650, Carestation 650c
Advice regarding a device modification. HPRA Ref: V33645
DePuy Synthes
Impactor for PFNA Blade
Advice regarding a device removal. HPRA Ref: V30236
DePuy Synthes
Acetabular Cup Introducer (32mm)
Advice regarding a device removal. HPRA Ref: V33657
Draeger Medical Systems Inc.
Dual Hemo MCable pod used with the Infinity Acute Care System (IACS)
Advice regarding a device modification. HPRA Ref: V33471
Endologix
Nellix EndoVascular Aneurysm Sealing System
Advice regarding the use of the device. HPRA Ref: V33504
Fisher & Paykel Healthcare
RT021 Catheter Mount
Advice regarding a device removal. HPRA Ref: V33531
Hill-Rom
Liko® Multirall™ 200 and S65
Advice regarding the use of the device. HPRA Ref: V33533
HMT Medizintechnik
PLEGIOX Cardioplegia Heat Exchanger
Advice regarding the use of the device. HPRA Ref: V33398
HTL-STREFA SA
Microdot Droplet Pen Needle 4mm x 32G28G, type 810
Advice regarding a device modification. HPRA Ref: V33449
Intelerad
Intelepacs Versions 3.5.1 and up
Advice regarding a software upgrade. HPRA Ref: V33411
LivaNova
Perfusion Tubing System Packs
Advice regarding a device removal. HPRA Ref: V33542
Maquet
Atrium Thoracic Catheters
Advice regarding changes/updates made to instructions for use. HPRA Ref: V30674
Maquet Cardiopulmonary GmbH
Heater-Cooler Units HCU 20 and HCU 30
Advice regarding changes/updates made to instructions for use. HPRA Ref: V33660
Maxter
MAXTER ENTRAL* ENFIT® NASOGASTRIC (NG) FEEDING TUBES
Advice regarding a device removal. HPRA Ref: V30605
Medacta
GMK Primary PS and GMK Sphere Tibial Insert
Advice regarding the use of the device. HPRA Ref: V33481
Medacta
GMK Hinge System
Advice regarding changes/updates made to instructions for use. HPRA Ref: V33648
Mediplus Limited
Silicone 2 way Foley Catheter Kit, 16Fr., Open Tip, Standard
Advice regarding a device removal. HPRA Ref: V33562
Medline Industries
Soft suction liner 3000cc/ml (with tube / Med-Gel) 3L MED-SOFT Liner
Advice regarding a device removal. HPRA Ref: V33667
Medtronic
FlexCath Advance™ Steerable Sheath
Advice regarding changes/updates made to instructions for use. HPRA Ref: V33548
Medtronic
Neuray® Neurosurgical Patties and Strips and Merocel® Neurosurgical Patties and Packing
Advice regarding changes/updates made to instructions for use. HPRA Ref: V33343
Oculentis
Lentis foldable Intraocular lenses
Advice regarding a device removal. HPRA Ref: V33214
ottobock
Voyager Evo - Rigid Frame Wheelchair
Advice regarding a device modification. HPRA Ref: V33544
Pentax
PENTAX Endsopes (multiple types)
Advice regarding a device modification. HPRA Ref: V33601
Philips Healthcare
SureSigns VSi, SureSigns VS2+ monitors
Advice regarding changes/updates made to instructions for use. HPRA Ref: V33253
Philips Healthcare
Philips M1783A/M5526A Sync Cables & 989803195641 ECG Out Cables
Advice regarding a device removal. HPRA Ref: V22727
Philips Medical Systems
Mobile Detector Holder
Advice regarding a device modification. HPRA Ref: V33086
Philips Medical Systems
Brilliance 64/ Ingenuity CT / Ingenuity Core / Ingenuity Core128
Advice regarding a software upgrade. HPRA Ref: V33181
Radiometer
TCM5 FLEX/BASIC used with ECG Monitors
Advice regarding the use of the device. HPRA Ref: V33532
Siemens Healthineers
Artis Zee, Artis Q Systems, with software version VD11C
Advice regarding a software upgrade. HPRA Ref: V33108
Siemens Healthineers
Artis system wireless foot switches delivered after January 1, 2005
Advice regarding a device modification. HPRA Ref: V30956
Smiths Medical
CADD® Medication Cassette Reservoirs (Non Flow-Stop), 50ml and 100ml
Advice regarding a device removal. HPRA Ref: V33553
Stago
Néoplastine® CI Plus 2, Néoplastine® CI Plus 5, STA - Néoplastine® CI 5, STA - Néoplastine® CI Plus 5
Advice regarding the use of the device. HPRA Ref: V33603
Stryker Orthopaedics
MAKO PKA & THA software of RIO system (MAKO Robot)
Advice regarding a software upgrade. HPRA Ref: V33193
Stryker Orthopaedics
rHead® System Radial Head Arthroplasty / Uni Elbow
Advice regarding a device removal. HPRA Ref: V33602
Teleflex Medical
WECK® Auto Endo5® Automatic Hem-o-lok® Clip Appliers
Advice regarding a device removal. HPRA Ref: V33508
Vascutek Ltd.
Anaconda™ ONE-LOK™ AAA Stent Graft System; Anaconda™ Iliac Stent Graft System; Anaconda™ AAA Stent Graft System Aortic Cuff
Advice regarding changes/updates made to instructions for use. HPRA Ref: V33417
Vygon
Premicath Neonatal PICC with Stylet
Advice regarding changes/updates made to instructions for use. HPRA Ref: V33254
Vygon
Octopus extension lines
Advice regarding a device removal. HPRA Ref: V33598
Wilson Instruments (Shanghai) Co. Ltd.
Disposable Cleaning Brush
Advice regarding changes/updates made to instructions for use. HPRA Ref: V32698
Zimmer Biomet
Pulsavac Plus Device. FSN 1
Pulsavac Plus Device. FSN 2
Advice regarding the use of the device. HPRA Ref: V33526
Zimmer Biomet
Hex Driver, 2.5 mm with GemLock® Retention
Advice regarding a device removal. HPRA Ref: V33569
Zimmer Biomet
Specific Hip and Trauma Instruments
Advice regarding a device removal. HPRA Ref: V33461
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Date Printed: 29/03/2023